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Reducing or Maintaining the Dose of Subcutaneous Tocilizumab in Patients With Rheumatoid Arthritis in Clinical Remission: A Randomized, Open‐Label Trial
Author(s) -
Sanmarti Raimon,
Veale Douglas J.,
MartinMola Emilio,
EscuderoContreras Alejandro,
González Carlos,
Ercole Liliana,
Alonso Rocío,
Fonseca João E.
Publication year - 2019
Publication title -
arthritis and rheumatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.106
H-Index - 314
eISSN - 2326-5205
pISSN - 2326-5191
DOI - 10.1002/art.40905
Subject(s) - tocilizumab , medicine , rheumatoid arthritis , randomized controlled trial , regimen , clinical trial , gastroenterology , surgery
Objective To evaluate the efficacy and safety of increasing the dose interval of subcutaneous tocilizumab (TCZ‐SC) in patients with rheumatoid arthritis (RA) who are in clinical remission. Methods RA patients with active disease and an inadequate response to conventional synthetic disease‐modifying antirheumatic drugs (csDMARDs) or to a biologic agent were entered into a single‐arm treatment phase with 162 mg of TCZ‐SC administered once weekly (TCZ‐SC 162 mg qw) as monotherapy or in combination with a csDMARD for 24 weeks. Patients who achieved clinical remission at weeks 20 and 24 were randomized to continue with the same regimen or to switch to 162 mg TCZ‐SC administered every 2 weeks (TCZ‐SC 162 mg q2w) for 24 weeks (open‐label). Patients with a Disease Activity Score in 28 joints (DAS28) of <2.6 were considered to be in clinical remission. Results In total, 179 (45%) of 401 patients in the single‐arm phase achieved clinical remission and were randomized to continue to receive TCZ‐SC 162 mg qw (n = 89) or to switch to TCZ‐SC 162 mg q2w (n = 90) for 24 weeks. At week 48, significantly more patients treated with TCZ‐SC 162 mg qw remained in clinical remission compared to patients who received TCZ‐SC 162 mg q2w (90% versus 73%; P = 0.004). The results of other efficacy measures revealed greater efficacy with TCZ‐SC 162 mg qw, but none of the efficacy outcomes in this group were significantly different from those in patients treated with TCZ‐SC 162 mg q2w, except for the mean change from baseline in the DAS28 score at week 48 (mean change −4.07 points [SD 1.29] versus −3.65 points [SD 1.35]; P = 0.034). Tolerability and safety parameters were similar between the treatment groups. Conclusion Increasing the dose interval of TCZ‐SC in patients with RA was associated with a lower likelihood of maintaining remission after 24 weeks and was not associated with better tolerability. However, most patients were able to sustain remission with a half‐dose of TCZ‐SC, and therefore this strategy deserves further investigation.